Sr. Specialist, Engineering (Onsite)

Merck & Co.; Elmora (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co. in Rahway, NJ, is seeking a Senior Specialist Sterile Process Engineer to lead the development and manufacturing of sterile clinical drug products at the FLEx GMP facility.

The role will drive process transfers, scale-up activities, investigations, and change management to ensure quality and rapid delivery of pipeline materials. You will author GMP SOPs and current GXP documents, collaborate with development scientists, operations, and quality, and report to the Sterile Process

Qualifications

• Bachelor’s degree in Chemical Engineering or related field with 5+ years relevant experience.
• Master’s degree in Chemical Engineering or related field with 3+ years relevant experience.
• PhD in Chemical Engineering or related field with relevant experience.

Responsibilities

• Lead process transfers and scale-up for sterile clinical drug products.
• Develop SOPs and GMP documentation for operations.
• Collaborate with development scientists, operations, and quality teams.

Skills

Leadership

Communication

Quality investigations

GMP compliance

Process design

Data analysis

SOP writing

Sterile processing

Problem solving

Education

Bachelor's degree in Chemical Engineering

Master's degree in Chemical Engineering

PhD in Chemical Engineering

Job description

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.

The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization.

This role will directly support the pipeline's most technically complex formulations and process development through process tech transfers, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the development scientists, engineers, operations, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline.

The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD).

Education Minimum Requirements

• Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience
• Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years of relevant experience, or a
• PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of -years of relevant experience.

Required Experience and Skills

• Excellent enterprise leadership skill demonstration
• Excellent interpersonal and communication skills, both verbal and written.
• Experience in leading quality investigations and change management.
• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• Experience with quality systems.
• Excellent organizational skills.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

Preferred Experience and Skills

• Experience with sterile GMP facility startup.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Expertise in drug product aseptic processing, equipment, and sterile technique.

Required Skills

• Adaptability
• Adaptability
• Analytical Testing
• Change Management
• Chemical Engineering
• Clinical Trials Operations
• Data Analysis
• Detail-Oriented
• Deviation Management
• Equipment Qualification
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Medical Supply Management
• Medicinal Chemistry
• Pharmaceutical Sciences
• Process Design
• Process Hazard Analysis (PHA)
• Process Optimization
• Root Cause Analysis (RCA)
• Standard Operating Procedure (SOP)
• Standard Operating Procedure (SOP) Development
• Sterile Procedures
• Strategic Thinking
• Technical Leadership
• Technical Problem-Solving {+ 1 more}

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a